ISPE Digital Validation Good Practice Guide
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ISPE Digital Validation Good Practice Guide
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このコンテンツについて
Based on the sources provided, Digital Validation Tools (DVTs) are software programs or systems designed to replace traditional paper documentation methods in the life sciences industry, crucial for managing activities like requirements, test execution, and results, while maintaining robust audit trails. The ISPE Good Practice Guide: Digital Validation offers practical, risk-based best practices for defining, implementing, and managing these tools within a regulated environment, exploring key concepts such as data integrity (ALCOA++), culture change, and integration with other systems. Adopting DVTs presents challenges related to implementation, governance, system integration, and regulatory adherence, but offers significant benefits, including enhanced data integrity, improved efficiency, streamlined audits, cost savings through paper reduction, and maintaining compliance with regulations like FDA 21 CFR Part 11 and EU Annex 11, often leveraging principles from ISPE GAMP® 5.